drugset / Press release

Sun Pharma gets USFDA tentative approval for generic Depakote ® delayed release tablets

2008-02-14 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 Registered Office : SPARC, Tandalja, Vadodara – 390 020. India FOR IMMEDIATE RELEASE Sun Pharma gets USFDA approval for generic Depakote ® delayed release tablets Mumbai, July 30, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for generic Depakote ®, d ivalproex sodium delayed release tablets. Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches. These generic versions of divalproex sodium delayed release 125 mg, 250 mg and 500 mg (valproic acid activity) tablets are bio-equivalent to Depakote ® delayed release tablets distributed by Abbott Laboratories. These strengths of Depakote ® delayed release tablets have annual sales of approximately USD 750 million in the US. These products will reach market shortly. Depako e ® is a registered trademark of Abbott Laboratories. t About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Indust ries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an international, integrated, sp eciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulat ions as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information abou t the company can be found at www.sunpharma.com. Contacts Uday Baldota Mira Desai Tel +91 22 6645 5645, Xtn 605 Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455605 Tel Direct +91 22 66455606 Mobile +91 98670 10529 Mobile +91 98219 23797 E mail [email protected] E mail [email protected] Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India

The release as fetched from its publisher. sunpharma.com ↗